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Dental Lithium Disilicate Glass Ceramic is available using CAD/CAM and hot pressing techniques for the preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges.

Dental Lithium Disilicate Glass-Ceramic is a lithium disilicate ceramic to be supplied in the form of cuboid and cylinder. Dental Lithium Disilicate Glass-Ceramic can be fabricated using CAD/CAM and hot pressing technologies. The device is a glass type material used for aesthetic purposes of full ceramic crowns, inlays, onlays, veneer and full ceramic 3unit anterior bridges. The ceramics material is composed of SiO2, Li2O, K2O, P2O5, A12O3, ZrO2 and other oxides. It contains inorganic pigments. The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.

The provided text describes a 510(k) premarket notification for a dental device, Dental Lithium Disilicate Glass Ceramic. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, the information typically associated with studies proving device performance, especially in the context of AI/ML or diagnostic devices, is not present here.

Based on the provided information, I can extract the acceptance criteria and details about the study (which is non-clinical bench testing) that demonstrates the device meets these criteria. However, many of the specific questions you asked (e.g., sample size for test set/training set, number of experts for ground truth, MRMC study details, standalone performance, data provenance) are not applicable because this is a submission for a material, not a diagnostic or AI-driven device.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are established based on relevant ISO standards for dental ceramic materials and the performance of the predicate device.

Study Details

The study conducted to demonstrate that the device meets the acceptance criteria was a series of non-clinical bench tests.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text. Bench tests would typically use a certain number of test specimens for each physical and chemical property evaluation, but the exact count is not detailed.
   • Data Provenance: The tests were conducted by the manufacturer, Liaoning Rachcera Material Technology Co.,Ltd., based in China. The data would therefore be laboratory-generated. It is inherently "prospective" in the sense that the tests were performed specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For material testing, "ground truth" is typically established by physical and chemical measurement standards (e.g., ISO, ASTM). The "experts" would be the laboratory personnel performing and interpreting the standardized tests, not external adjudicators as in clinical or AI studies.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • None Applicable. This concept is relevant for human-interpreted data, often in diagnostic studies. Bench tests follow standardized procedures, where results are measured directly against numerical criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable. This is a material (glass ceramic) and not an AI or diagnostic device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a material and not an algorithm. The "standalone performance" is simply the material's physical and chemical properties as measured in the lab.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Standardized Measurement Values: The "ground truth" for the non-clinical tests is based on the specifications outlined in international standards (e.g., ISO 6872:2015, ISO 7405:2018, ISO 10993 series) and the measured values from physical and chemical tests.

7. The sample size for the training set:

   • Not Applicable. This is a material, not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. No training set for this type of device.

Summary of the Study:

The study was a comprehensive non-clinical bench testing program. This program verified that the Dental Lithium Disilicate Glass Ceramic meets the established performance requirements and safety standards for dental ceramic materials, aligning with relevant ISO standards (ISO 6872:2015 for ceramic materials, and ISO 7405, ISO 10993 series for biocompatibility). The results of these tests demonstrated that the proposed device exhibits physical, chemical, and biological properties that are substantially equivalent to the predicate device (K230487). Specifically, the device achieved or exceeded all specified criteria for mechanical strength, thermal properties, solubility, shrinkage, radioactivity, and biocompatibility. The submission states that "The conclusions drawn from the nonclinical tests demonstrate that subject device Dental Lithium Disilicate Glass Ceramic is as safe and effective as the predicate device."

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